U.S. health advisers on Friday tackled who should get boosters of Johnson & Johnson's single-shot COVID-19 vaccine and when - and whether using a competing brand for the second dose might provide better protection. The push for boosters kicked off last month after the Food and Drug Administration authorized third doses of the Pfizer vaccine for seniors and younger adults with health problems, jobs or living conditions that place them at higher risk from the coronavirus. On Thursday, an FDA advisory panel unanimously recommended a half-dose booster of the similar Moderna vaccine for the same groups. Friday, the same panel discussed a booster of J&J's vaccine but the decision is more complex. Moderna and Pfizer asked the FDA to OK boosters at least six months after immunization, but J&J proposed a sliding schedule with an extra dose as early as two months later. Adding another twist, the experts also will discuss preliminary data from a government mix-and-match study that ...
The FDA panel will meet on Thursday and Friday to weigh the evidence for booster doses
SEC asks J&J to monitor adverse events closely for next three months
Drug cuts hospitalisation, deaths by 50%, shows an analysis of a late-stage trial
J&J said a booster given two months after the first dose increased antibody levels four to six-fold
According to sources, discussions are on between J&J and the Centre on the matter of indemnity against any serious adverse effect after vaccination
The company said on Friday that it had submitted an application to the Central Drugs Standard Control Organisation (CDSCO) on August 17 in this regard
To achieve herd immunity, studies have to be done on children, pharma major says
Duato, 59, currently serves as vice chairman of J&J's executive committee
Johnson & Johnson will replace Chairman and CEO Alex Gorsky with another veteran company executive starting next year. The world's biggest maker of health care products said late Thursday that Joaquin Duato will become CEO and a member of the company's board of directors on January 3. Duato currently serves as vice chairman of J&J's executive committee, which involves working with the company's pharmaceutical and health sectors and overseeing its global supply chain. Duato, a dual citizen of Spain and the United States, has been with Johnson & Johnson for more than 30 years, the company said. Gorsky has served as chairman and CEO since 2012 and will become executive chairman of the board. J&J reported a 73 per cent jump in second-quarter profit last month, driven by strong sales growth as hospitals and other parts of the health care industry rebounded from COVID-19 pandemic slowdowns the previous year. The New Brunswick, New Jersey, company made more than USD 6 billion
Studies show the US company's vaccine has 66 percent efficacy against preventing moderate to severe Covid-19.
Pace has increased but supply constraints remain
J&J did not divulge details of when the vaccine will be available in India and what kind of initial volumes can be expected
It is not clear whether J&J is seeking indemnity against adverse events following vaccination like its US peers
Global healthcare major Johnson & Johnson on Friday said it has applied for Emergency Use Authorization (EUA) of its single-dose COVID-19 vaccine in India. Earlier on Monday, the company had said that it remained committed to bringing its single-dose COVID-19 vaccine to India and looks forward to ongoing discussions with the Indian government. "On August 5, 2021 Johnson & Johnson Pvt Ltd applied for EUA of its single-dose COVID-19 vaccine to the government of India," a Johnson & Johnson India spokesperson said in a statement. This is an important milestone that paves the way for bringing the company's single-dose COVID-19 vaccine to the people of India, and the rest of the world, through a collaboration with Biological E Limited, the statement added. "Biological E will be an important part of our global supply chain network, helping to supply our Johnson & Johnson COVID-19 vaccine through the extensive collaborations and partnerships we have with governments, health ...
Federal health regulators on Wednesday again extended the expiration dates on Johnson & Johnson's COVID-19 vaccine, providing health workers with six more weeks to use millions of doses of the shot. The Food and Drug Administration said in a letter to J&J that the shots remain safe and effective for at least six months when properly stored and refrigerated. It's the second time the FDA has extended the shelf life on the vaccines since June, when the agency said they could be used for up to 4 1/2 months. When first authorized in February, the FDA said the vaccines could be stored for three months at normal refrigeration levels. Health authorities in many states had recently warned that they could be forced to throw out thousands of doses of the one-shot vaccine without an extension. The change gives health providers more time to use remaining shots sitting at pharmacies, hospitals and clinics. After plateauing earlier this summer, vaccination rates have begun climbing again as .
The delta variant has some characteristics that give it a better chance of causing an infection, which means it escapes initial shield provided by antibodies, but vaccinated people are at a lower risk
Bharti Pravin Pawar says Centre has set up team to deal with various issues related to procurement of Covid-19 vaccine from foreign firms
The benefits of the Johnson & Johnson Covid-19 vaccine far outweigh its potential risks amid an ongoing review of reports of a rare neurological disorder, according to an advisory panel to the US Centers for Disease Control and Prevention (CDC) on Thursday.
Under the settlement proposal, McKesson Corp, Cardinal Health Inc and AmerisourceBergen Corp- are expected to pay a combined $21 billion, while drugmaker Johnson & Johnson would pay $5 billion